The ARIES Norovirus Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients. The purpose of this study is to establish the diagnostic accuracy of ARIES Norovirus Assay.
The ARIES Norovirus Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients. The objective is to establish the diagnostic accuracy of the ARIES Norovirus assay through a multi-site, method comparison on prospectively collected leftover, stool specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement)
Study Type
OBSERVATIONAL
Enrollment
500
UCLA
Los Angeles, California, United States
RECRUITINGChildren's Hospital Colorado
Aurora, Colorado, United States
RECRUITINGIndiana Health
Indianapolis, Indiana, United States
Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by ARIES Norovirus Assay.
Time frame: Within the first year of sample collection
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGGeisinger Medical Laboratories
Danville, Pennsylvania, United States
RECRUITING